Inspra

Treats hypertension. NDA 21437, held by Upjohn. Eplerenone.

As of Nov 14, 2026, NDA 21437 (Inspra), held by Upjohn, was first approved by FDA on Sep 27, 2002, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2002
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INSPRA is an aldosterone antagonist indicated for:

Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction.
The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Heart Failure Post-Myocardial Infarction INSPRA is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Jan 31, 2008	Supplement 5Efficacy (new indication or use)	Approved	Letter Label Pediatric Memo Pediatric Statistical Review
Oct 7, 2003	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Sep 27, 2002	Original applicationNew molecular entity	Approved	Review Letter Label

Products

3 strengths and forms


Inspra25MG · tablet;oral	Eplerenone	RxReference drug
Inspra50MG · tablet;oral	Eplerenone	RxReference drug
Inspra100MG · tablet;oral	Eplerenone	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 16, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
May 30, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
May 4, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 26, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
May 16, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 15, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 22, 2012	Supplement 9Labeling	Approved	Letter Label Letter Label
May 7, 2008	Supplement 6Labeling · Standard review	Approved	Label Letter
Jan 31, 2008	Supplement 5Efficacy (new indication or use)	Approved	Letter Label Pediatric Memo Pediatric Statistical Review
Oct 7, 2003	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Sep 27, 2002	Original applicationNew molecular entity	Approved	Review Letter Label

Identifiers

Application: NDA 21437
Drugs@FDA: Overview at FDA
Company: Upjohn

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters